Surgical Gut Suture
FDA 510(k) clearance K142656 · decided 2015-01-29
Clearance details
- K-number
- K142656
- Device name
- Surgical Gut Suture
- Applicant
- Covidien
- Decision
- Substantially Equivalent
- Date received
- 2014-09-18
- Decision date
- 2015-01-29
- Days to decision
- 133 days
- Clearance type
- Special
- Product code
- GAL
- Device class
- 2
- Regulation number
- 878.4830
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- North Haven, 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 |
|---|---|---|
| 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 |
| AILEE SUTURES AND AILEE NEEDLES (K982646) | Myco Medical Supplies, Inc. | 1999-06-02 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR G recall (Z-1388-2023) | Covidien, LP | 2023-04-12 |
| Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT recall (Z-1389-2023) | Covidien, LP | 2023-04-12 |
| Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC- recall (Z-1390-2023) | Covidien, LP | 2023-04-12 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S006) | Covidien | 1997-06-24 |
| MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S005) | Covidien | 1995-12-28 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S004) | Covidien | 1995-06-14 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S003) | Covidien | 1994-06-17 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S002) | Covidien | 1994-03-28 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S001) | Covidien | 1993-09-10 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034) | Covidien | 1991-12-13 |