Atlas FDA

SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES

FDA 510(k) clearance K930825 · decided 1994-01-07

Clearance details

K-number
K930825
Device name
SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES
Applicant
Surgical Specialties, Inc.
Decision
Substantially Equivalent
Date received
1993-02-17
Decision date
1994-01-07
Days to decision
324 days
Clearance type
Traditional
Product code
GAP
Device class
2
Regulation number
878.5030
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Readding, PA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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RecordFirmDate
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SILK Surgical Suture (K162396)Teleflexmedical, Inc.2016-11-23
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture (K160623)M/s. Meril Endo Surgery Private Limited.2016-05-31
WG-SURGICAL SUTURES WITH NEEDLE (K080684)Foosin Medical Supplies, Inc.2008-06-09
NON-ABSORBABLE SILK SUTURE (K071111)Arrow Intl., Inc.2007-07-17
MANI NEEDLE & SUTURE PACK (SILK) (K053638)Mani, Inc.2006-05-19
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE (K041514)Sutures India Private Limited2005-06-03

Recalls involving this device

RecordFirmDate
3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended f recall (Z-0034-2009)Surgical Specialties Corp2008-10-02