DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.
FDA 510(k) clearance K900198 · decided 1990-07-05
Clearance details
- K-number
- K900198
- Device name
- DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.
- Applicant
- American Cyanamid Co.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1990-01-16
- Decision date
- 1990-07-05
- Days to decision
- 170 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
- Danbury, CT, 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 |
| ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED (K920978) | ETHICON, Inc. | 1994-02-15 |
| 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.