DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT
FDA 510(k) clearance K930586 · decided 1993-12-17
Clearance details
- K-number
- K930586
- Device name
- DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT
- 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
- GAR
- Device class
- 2
- Regulation number
- 878.5020
- 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 |
|---|---|---|
| Tissue Approximation System (K261484) | Tas Medical, Inc. | 2026-06-03 |
| Tissue Approximation System (TAS) (K220980) | Tas Medical, Inc. | 2023-07-05 |
| Golnit Nylon Monofilament Suture (K212888) | Antarma, LLC Dba Golnit Sutures | 2022-03-31 |
| Non Absorbable Surgical Nylon Suture (K212603) | Shandong Haidike Medical Product Co., Ltd. | 2021-12-22 |
| Crownjun Nylon Suture (K192420) | Kono Seisakusho Co., Ltd. | 2020-05-29 |
| REXLON, REXSIL (K161633) | Sm Eng Co., Ltd. | 2017-03-02 |
| Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (K151165) | Aesculap, Inc. | 2016-02-17 |
| RiverLon (Nylon) Suture (K152795) | Riverpoint Medical | 2015-10-28 |
| VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED (K123034) | Unilene Sac | 2013-05-28 |
| KUMAR T-ANCHORS HERNIA SET (K081366) | Nashville Surgical Instruments | 2008-07-15 |
| FSSB NYLON SURGICAL SUTURES (K060471) | Fssb Chirurgische Nadeln GmbH | 2006-07-26 |
| MANI NEEDLE & SUTURE PACK (NYLON) (K053637) | Mani, Inc. | 2006-05-19 |
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 |