ETHICON RETRACTION TAPE
FDA 510(k) clearance K801699 · decided 1980-09-26
Clearance details
- K-number
- K801699
- Device name
- ETHICON RETRACTION TAPE
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-07-23
- Decision date
- 1980-09-26
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- GAD
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, 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 |
|---|---|---|
| JRP Wound Spreader (K152538) | J.R. Parker, LLC | 2016-04-13 |
| OTELO LL (K151104) | Spineart | 2016-01-06 |
| THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES (K132645) | Medtronic, Inc. | 2013-10-04 |
| DASH (K071775) | Ezsurgical | 2007-08-07 |
| APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR (K050256) | Apple Medical Corp. | 2005-04-26 |
| QUADRANT RETRACTOR SYSTEM (K043602) | Medtronic Sofamor Danek | 2005-02-23 |
| MRI FASTSYSTEM RETRACTOR SYSTEM (K001339) | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 2000-05-17 |
| CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (K980588) | Clarus Medical Systems, Inc. | 1998-08-18 |
| SCION SAPHENOUS VEIN HARVESTING SYSTEM (K963006) | Scion International, Inc. | 1996-09-20 |
| VILLALTA RETRACTOR (K943875) | Hct, Inc. | 1994-11-09 |
| RETRACTOR (K942002) | Automated Medical Products Corp. | 1994-05-17 |
| RETRACTOR (K941448) | Technovations | 1994-04-15 |
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 |