PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR
FDA 510(k) clearance K930589 · decided 1993-12-17
Clearance details
- K-number
- K930589
- Device name
- PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR
- Applicant
- Davis & Geck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-02-04
- Decision date
- 1993-12-17
- Days to decision
- 316 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
- Danbury, CT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Davis & Geck
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 |
|---|---|---|
| MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S008) | Davis & Geck, Inc. | 1996-11-15 |
| MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S007) | Davis & Geck, Inc. | 1996-01-11 |
| NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE (P840041/S006) | Davis & Geck, Inc. | 1996-01-11 |
| NOVAFIL(TM) (P840041/S005) | Davis & Geck, Inc. | 1994-04-20 |
| MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S006) | Davis & Geck, Inc. | 1992-03-24 |
| MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S005) | Davis & Geck, Inc. | 1991-10-17 |
| MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S004) | Davis & Geck, Inc. | 1991-03-29 |
| NOVAFIL(TM) (P840041/S003) | Davis & Geck, Inc. | 1990-07-06 |