SURGILON, DERMALON, & OPHTHALON— 510(k) K981582
Substantially EquivalentDavis & Geck, Inc.
FDA 510(k) clearance K981582 for SURGILON, DERMALON, & OPHTHALON, Substantially Equivalent on 1998-07-13. Applicant: Davis & Geck, Inc.. Device class: 2.
Clearance details
- Applicant
- Davis & Geck, Inc.
- Product code
- Code GAR
- Device class
- Class 2
- Regulation
- 21 CFR 878.5020
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazlewood, MO, US
Recent devices under product code GAR
view allMore clearances from Davis & Geck, Inc.
view all- K982853 — SILK SUTURE
- K974015 — ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL
- K980610 — DEXON RAPID (DEXON R)
- K980062 — MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE
- K973409 — KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS
Adverse events under product code GAR
product code GAR- Injury
- 422
- Malfunction
- 3,386
- Other
- 4
- Total
- 3,812
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K981582
K-number listed on FDA's recall record- Z-2920-2026 — Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
- Z-0844-2024 — Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT
- Z-1172-2023 — Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMALON* 6-0 BLU 45CM C13 (5) 88861757-41 DERMALON* 3-0 BLU 75CM C13
- Z-1178-2023 — Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 BLK 7X75CM PCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT 88861932-51 SURGILON* 2-0 BLK 75CM GS10 88861971-71 SURGILON* 1 BLK 75CM GS21 88861985-71 SURGILON* 1 BLK 75CM SC1X36 SBS-1884G SURGILON* 4-0 WHI 45CM P12X12 SBS-1928G SURGILON* 5-0 BLK 45CM P13X12
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981582.
Data sourced from openFDA. This site is unofficial and independent of the FDA.