ENDOSTAPLE
FDA 510(k) clearance K911829 · decided 1991-08-28
Clearance details
- K-number
- K911829
- Device name
- ENDOSTAPLE
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-04-24
- Decision date
- 1991-08-28
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- GCI
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Somerville, NJ, 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 |
|---|---|---|
| DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR (K021747) | Surgicon, Inc. | 2002-08-15 |
| MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (K003222) | Computer Motion, Inc. | 2000-11-03 |
| KARL STORZ 3D VIDEO SYSTEM (K001362) | Karl Storz Imaging, Inc. | 2000-07-17 |
| BOOTY ENDOSCOPE WARMER (K933515) | T-Med, Inc. | 1993-10-27 |
| BIRTCHER SURE CLEAN INSTRUMENT SYSTEM (K930302) | Birtcher Medical Systems, Inc. | 1993-10-27 |
| GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS (K930496) | Birtcher Medical Systems, Inc. | 1993-04-20 |
| AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH (K922123) | United States Surgical, A Division of Tyco Healthc | 1993-02-01 |
| GLEESON CLOT-BUSTER (K920139) | Conmedcorp | 1992-04-15 |
| POOLE TIP SUCTION PROBE (K915762) | O.R. Concepts, Inc. | 1992-03-13 |
| SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT (K914120) | Conmedcorp | 1991-10-30 |
| ENDOSCOPE AND ACCESSORIES (K905117) | Northgate Technologies, Inc. | 1991-04-25 |
| SURGITRON (K911461) | Ellman Intl. Mfg., Inc. | 1991-04-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ETHIZIA (P240035) | ETHICON, Inc. | 2025-12-15 |
| INTERCEED Absorbable Adhesion Barrier (P880047/S068) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S127) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S122) | ETHICON, Inc. | 2025-11-04 |
| SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126) | ETHICON, Inc. | 2025-10-09 |
| GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067) | ETHICON, Inc. | 2025-10-09 |
| SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125) | ETHICON, Inc. | 2025-09-24 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S066) | ETHICON, Inc. | 2025-09-24 |