Atlas FDA

SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC

FDA 510(k) clearance K930738 · decided 1994-07-26

Clearance details

K-number
K930738
Device name
SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC
Applicant
Deknatel, Inc.
Decision
Substantially Equivalent
Date received
1993-02-12
Decision date
1994-07-26
Days to decision
529 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
San Jose-Heredia, CR
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Surgical Gut Suture (K142656)Covidien2015-01-29
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 Incorporated2003-03-17
SERRALGUT (K020597)Serral, S.A. DE C.V.2002-08-14
GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC (K021043)Gramsmed, LLC2002-06-21
SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE (K011105)Qrc Consulting2001-05-30
PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP (K001299)Cp Medical2000-06-23
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

RecordFirmDate
Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated f recall (Z-1555-2014)Teleflex Medical2014-05-07
Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distribu recall (Z-1556-2014)Teleflex Medical2014-05-07
Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed recall (Z-1557-2014)Teleflex Medical2014-05-07
Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbab recall (Z-1558-2014)Teleflex Medical2014-05-07
Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC recall (Z-1559-2014)Teleflex Medical2014-05-07
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture recall (Z-1560-2014)Teleflex Medical2014-05-07
Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S recall (Z-1561-2014)Teleflex Medical2014-05-07
Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-7 recall (Z-1497-2014)Teleflex Medical2014-04-24
Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK BL MF 0 TC-43 2N 48, Catalog #83 recall (Z-1018-2007)Teleflex Creek Dr2007-07-17

PMA approvals by this applicant

RecordFirmDate
NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S006)Deknatel, Inc.1989-06-16
NONABSORBABLE SURG. SUTURES, NYLON (N85060/S007)Deknatel, Inc.1989-06-16
DEKLENE(TM) (P810028/S011)Deknatel, Inc.1989-06-16
DEKLENE(TM) (P810028/S010)Deknatel, Inc.1989-02-02
NONABSORBABLE SURG. SUTURES, NYLON (N85060/S005)Deknatel, Inc.1989-01-31
DEKLENE(TM) (P810028/S008)Deknatel, Inc.1989-01-31
CHROMIC GUT SUTURE (N84381/S007)Deknatel, Inc.1989-01-31
NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S004)Deknatel, Inc.1989-01-31