GUT SUTURES
FDA 510(k) clearance K896554 · decided 1990-05-31
Clearance details
- K-number
- K896554
- Device name
- GUT SUTURES
- Applicant
- Look, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1989-11-17
- Decision date
- 1990-05-31
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- GAL
- Device class
- 2
- Regulation number
- 878.4830
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Look
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Surgical Gut Suture (K142656) | Covidien | 2015-01-29 |
| DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT (K072930) | Demetech Corp. | 2008-04-30 |
| UNIPLAIN & UNICHROM (K042287) | United Medical Industries Co. , Ltd. | 2005-09-07 |
| AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE (K042897) | Ethicon Endo-Surgery, Inc. | 2004-11-19 |
| SUTURTEK FASTCLOSE SUTURING DEVICE (K030227) | Suturtek Incorporated | 2003-03-17 |
| SERRALGUT (K020597) | Serral, S.A. DE C.V. | 2002-08-14 |
| GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC (K021043) | Gramsmed, LLC | 2002-06-21 |
| SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE (K011105) | Qrc Consulting | 2001-05-30 |
| PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP (K001299) | Cp Medical | 2000-06-23 |
| PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP (K000542) | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-28 |
| LIGA-LOOP SUTURE APPLICATOR (K993695) | Hysterx, Inc. | 2000-04-13 |
| PLAIN/CHROMIC CATGUT (K994002) | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NON-ABSORBABLE BLACK SILK SUTURE (N83074/S004) | Look, Inc. | 1990-09-12 |
| NON-ABSORBABLE BLACK SILK SUTURE (N83074/S002) | Look, Inc. | 1986-06-09 |
| POLYVIOLENE SUTURE (N80950/S003) | Look, Inc. | 1986-06-09 |
| POLYVIOLENE SUTURE (N80950/S002) | Look, Inc. | 1986-02-28 |
| POLYVIOLENE SUTURE (N80950/S001) | Look, Inc. | 1985-03-22 |
| NON-ABSORBABLE BLACK SILK SUTURE (N83074/S001) | Look, Inc. | 1985-03-22 |