Atlas FDA

SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL

FDA 510(k) clearance K930740 · decided 1994-07-26

Clearance details

K-number
K930740
Device name
SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL
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
GAQ
Device class
2
Regulation number
878.4495
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
San Jose-Heredia, CR
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Deknatel

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.

RecordFirmDate
CoNextions TR Tendon Repair System (K203855)Conextions Medical2022-04-22
Wego-Stainless Steel (K193209)Foosin Medical Supplies Inc., Ltd.2020-02-19
MERISTEEL (K172146)M/s. Meril Endo Surgery Private Limited.2018-02-01
Surgical Stainless Steel Suture, Stainless Steel Suture (K170767)ETHICON, Inc.2017-11-01
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE (K141007)Demetech Corp.2014-09-25
FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP (K140127)Pontis Orthopaedics, LLC2014-05-28
FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 (K081060)Core Essence Orthopaedics, LLC2008-12-24
SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE (K082828)Suturtek Incorporated2008-10-14
SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 (K063603)Suturtek Incorporated2007-02-07
MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE (K042606)Synthes (Usa)2005-05-27
SYNTHES (USA) TITANIUM WIRE (K041333)Synthes (Usa)2004-08-27
SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE (K032468)Suturtek Incorporated2003-09-23

Recalls involving this device

RecordFirmDate
Various Types, Sterile/Nonsterile Stainless Steel Nonabsorable Surgical Sutures-SS Wire, S recall (Z-1015-2007)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