GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR
FDA 510(k) clearance K931340 · decided 1993-07-01
Clearance details
- K-number
- K931340
- Device name
- GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1993-03-16
- Decision date
- 1993-07-01
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- GCS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Niles, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LAPRASCOPIC GRASPER (K944062) | Instrument Makar, Inc. | 1995-02-23 |
| PEANUT WAND, MODIFICATION (K944067) | Ideal Medical, Inc. | 1994-12-08 |
| AESCULAP TROCAR INSTRUMENT SET (K933201) | Aesculap, Inc. | 1993-09-13 |
| 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT (K932762) | Inman Medical Corp. | 1993-08-31 |
| IMC ENDOSCOPIC INSTRUMENT HOLDER (K933371) | Inman Medical Corp. | 1993-08-06 |
| LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS (K924134) | Leisegang Medical, Inc. | 1993-07-02 |
| M.I.S. TROCAR-CANNULA (K925276) | M.I.S. Technology, Inc. | 1993-05-24 |
| LAPAROSCOPIC RETRACTOR SYSTEM (K921006) | Laparomed Corp. | 1992-07-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |