Data / Medical devices / United States / Sac LLC
Sac LLC: FDA-registered device maker in Sanford, FL, United States, 1 510(k) clearance
Sac LLC is registered with the FDA (registration 3008595179) in Sanford, FL, United States. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 6, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008595179
- Address
- 2526 Old Lake Mary Rd., Sanford, FL, United States, 32773
- Owner or operator
- SAC LLC dba Pinnacle Medical Surgical / Orange Surgical Inst (10033801)
- Roles
- Complaint file establishment
- First device listed
- June 20, 2022
- Registered through
- 2026
- Brand names listed
- Reusable Disposable Laparoscopic Instrument and Surgical Device and Accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Complaint file establishment | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Complaint file establishment | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Complaint file establishment | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Complaint file establishment | accessdata.fda.gov |
| Insufflator, Laparoscopic | HIF | 2 | Complaint file establishment | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Complaint file establishment | accessdata.fda.gov |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Complaint file establishment | accessdata.fda.gov |
| Stabilizer, Heart | MWS | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| June 6, 2011 | K101733 | REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES | GCJ | Substantially Equivalent | Sac, LLC Dba Pinnacle Medical Surgical | accessdata.fda.gov |
Compare with other makers
- All makers of Guide, Needle, Surgical
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Insufflator, Laparoscopic
- All makers of Drape, Surgical, Antimicrobial
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Laparoscope, Gynecologic (And Accessories)
Updated June 6, 2011. 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.