Atlas FDA

SURGILON, DERMALON, & OPHTHALON

FDA 510(k) clearance K981582 · decided 1998-07-13

Clearance details

K-number
K981582
Device name
SURGILON, DERMALON, & OPHTHALON
Applicant
Davis & Geck, Inc.
Decision
Substantially Equivalent
Date received
1998-05-04
Decision date
1998-07-13
Days to decision
70 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
Hazlewood, MO, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU recall (Z-2920-2026)Covidien, LP2026-08-07
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGIL recall (Z-0844-2024)Covidien LP2024-01-29
Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747 recall (Z-1172-2023)Covidien, LP2023-02-25
Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 recall (Z-1178-2023)Covidien, LP2023-02-25
Syneture Surgilon 5/0 Blk 5X18 T-37/CV-20 D-TACH non-absorbable braided nylon sutures Mate recall (Z-2820-2011)Covidien LP2011-07-15
Syneture Surgilon 0 Blk 3X18 CE-10/C-16 non-absorbable braided nylon sutures Material 8886 recall (Z-2821-2011)Covidien LP2011-07-15
Syneture Surgilon 0 Blk 5X18 T-12/GS-21 D-TACH non-absorbable braided nylon sutures Materi recall (Z-2822-2011)Covidien LP2011-07-15
Syneture Surgilon 0 Black 5X18 T-3/GS-23 D-TACH non-absorbable braided nylon sutures Mater recall (Z-2823-2011)Covidien LP2011-07-15
Syneture Surgilon 4/0 BLK 5X18 CV-22 D*TACH JLDT non-absorbable braided nylon sutures Mate recall (Z-2824-2011)Covidien LP2011-07-15

PMA approvals by this applicant

RecordFirmDate
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