Data / Medical devices / United States / Klein Surgical Systems, Inc.
Klein Surgical Systems, Inc.: FDA-registered device maker in San Antonio, TX, United States, 1 510(k) clearance
Klein Surgical Systems, Inc. is registered with the FDA (registration 1648701) in San Antonio, TX, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 20, 1993. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1648701
- FEI number
- 3000204261
- Address
- 400 N Loop 1604 E Ste 106, San Antonio, TX, United States, 78232
- Owner or operator
- KLEIN SURGICAL SYSTEMS, INC. (9026062)
- Roles
- Repackager or relabeler
- First device listed
- March 3, 2011
- Registered through
- 2026
- Brand names listed
- GI-1085 AKA 300-100-771, GI-1086 AKA 300-100-772,, GI-1085 AKA GI-1085U, GI-1095 AKA GI-1095U, GI-1088 AKA 300-400-775, GI-1090 AKA 300-100-773, GI-1095 AKA 300-100-774,, GI-1090, 1095, 1080, 1085, 1086, 1088, ENDOSCOPIC CLAMPS, Klein Applier, Klein Bulldog Clamp Applier, Klein Bulldogs and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applier, Surgical, Clip | GDO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Non-Electrical | FFN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Laryngoscope, Endoscope | GCI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 20, 1993 | K930496 | GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS | GCI | Substantially Equivalent | Birtcher Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Holder, Needle, Gastroenterologic
- All makers of Laryngoscope, Endoscope
- All makers of Applier, Surgical, Clip
- All makers of Clamp, Non-Electrical
- All makers of Tray, Surgical, Instrument
Updated April 20, 1993. 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.