Data / Medical devices / Germany / Spiggle & Theis Medizintechnik GMBH
Spiggle & Theis Medizintechnik GMBH: FDA-registered device maker in OVERATH North Rhine-Westphalia, Germany, 3 510(k) clearances
Spiggle & Theis Medizintechnik GMBH is registered with the FDA (registration 3002858762) in OVERATH North Rhine-Westphalia, Germany. It lists 62 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 3, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3002858762
- Address
- Burghof 14, OVERATH North Rhine-Westphalia, Germany, 51491
- Owner or operator
- SPIGGLE & THEIS MEDIZINTECHNIK GMBH (9050994)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 30, 2002
- Registered through
- 2026
- Brand names listed
- Block, Cutting, ENT, NON-STERILE, Bruening aural magnifier speculum set, Chisel Spiggle & Theis, Chisel, middle ear Spiggle Theis, Curette, Depressor, Metal Tongue Surgical, Drape, Robotic, sterile, ENT Bandages and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Balloon, Epistaxis | EMX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Repackager or relabeler | accessdata.fda.gov |
| Block, Cutting, Ent, Non-Sterile | NNR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Sinus | KAM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Middle-Ear | JYE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Nasal | KAN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp | HXD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Ear | JYG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Depressor, Metal Tongue, Surgical | KBL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dilator, Esophageal, Ent | KCF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Elevator, Ent | KAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Eustachian Tube Balloon Dilation Device | PNZ | 2 | Specification developer | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Specification developer | accessdata.fda.gov |
| Forceps, Wire Closure, Ent, Non-Sterile | NNQ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Fork, Tuning | GWX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gauge, Measuring | JYJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Specification developer | accessdata.fda.gov |
| Holder, Ear Speculum | JYK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Microsurgical Ear | JYL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Ent | KTG | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Light, Surgical Headlight | EBA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Loop, Wire | JYQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Loupe, Binocular, Low Power | HJH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mallet | HXL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mirror, Ent | KAI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Specification developer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Reusable | GDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Nipper, Malleus | JYR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Otoscope | ERA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Perforator, Ear-Lobe | JYS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Probe, Ent | KAK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Prosthesis, Partial Ossicular Replacement | ETB | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Protector, Dental | BRW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Ent | KTF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rasp, Nasal | KBA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Replacement, Ossicular Prosthesis, Total | ETA | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rod, Measuring Ear | JYZ | 1 | Specification developer | accessdata.fda.gov |
| Scissors, Ear | JZB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Nasal | KBD | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Snare, Tonsil | KBZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Source, Carrier, Fiberoptic Light | EQH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spectacle Microscope, Low-Vision | HKC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Splint, Intranasal Septal | LYA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Splint, Nasal | EPP | 1 | Manufacturer | accessdata.fda.gov |
| Spoon, Ear | JZE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Support, Head, Surgical, Ent | EPW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Table And Attachments, Operating-Room | BWN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Ent | MMO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Trocar, Ent | KTE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Aspirating, Flexible, Connecting | BYY | 2 | Specification developer | accessdata.fda.gov |
| Tube, Ear Suction | JZF | 1 | Specification developer | accessdata.fda.gov |
| Weights, Eyelid, External | MML | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| August 3, 2023 | K223542 | TubaVent Balloon Dilatation System | PNZ | Substantially Equivalent | Spiggle & Theis Medizintechnik GmbH | accessdata.fda.gov |
| March 3, 2003 | K030492 | TITANIUM OSSICULAR REPLACMENT SYSTEM | ETA | Substantially Equivalent | Invotec International, Inc. | accessdata.fda.gov |
| January 27, 2003 | K021750 | LID CHAIN EYELID WEIGHTS | MML | Substantially Equivalent | Jedmed Instrument Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|
| June 27, 2025 | 97229 | Class II | Ongoing | Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile | Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction. | accessdata.fda.gov |
Compare with other makers
Updated August 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.