ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED
FDA 510(k) clearance K920978 · decided 1994-02-15
Clearance details
- K-number
- K920978
- Device name
- ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-02
- Decision date
- 1994-02-15
- Days to decision
- 715 days
- Clearance type
- Traditional
- Product code
- GAN
- Device class
- 2
- Regulation number
- 878.4830
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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 |
|---|---|---|
| SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD (K003015) | Surgical Specialties Corp | 2000-12-15 |
| MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED (K964072) | ETHICON, Inc. | 1996-12-18 |
| MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) (K960653) | ETHICON, Inc. | 1996-03-28 |
| ORTHOPEDIC PACKS (K951231) | Sterile Concepts, Inc. | 1995-12-01 |
| DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. (K900198) | American Cyanamid Co. | 1990-07-05 |
| POLYSORB SYNTHETIC ABSORBABLE SUTURE (K895579) | United States Surgical, A Division of Tyco Healthc | 1990-07-05 |
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 |