Atlas FDA

POLYVIOLENE(TM) SUTURE

FDA 510(k) clearance K904054 · decided 1990-10-03

Clearance details

K-number
K904054
Device name
POLYVIOLENE(TM) SUTURE
Applicant
Look, Inc.
Decision
Substantially Equivalent
Date received
1990-07-31
Decision date
1990-10-03
Days to decision
64 days
Clearance type
Traditional
Product code
GAS
Device class
2
Regulation number
878.5000
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Ada, OK, US
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
RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene (K203120)Lsi Solutions, Inc.2020-11-24
RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture (K203081)Lsi Solutions2020-11-24
ARTHREX BIOWIRE (K091018)Arthrex, Inc.2010-07-30
MR-III (K002261)Smith & Nephew, Inc.2000-10-23
SUTURE CORD (K953128)Phoenix Biomedical Corp.1996-02-09
BRAIDED POLYESTER SUTURE MATERIAL (K923161)Mitek Surgical Products, Inc.1992-12-30
PETERS CARDIOFLON(TM) SUTURE (K913101)Promedica Products, Inc.1992-08-12
MITEK QUICKANCHOR(TM), MODIFICATION (K915089)Mitek Surgical Products, Inc.1992-02-03
MITEK SNAP PAK(TM), MODIFICATION (K915081)Mitek Surgical Products, Inc.1992-01-31
ADVANCE SUTURE NONABSORBABLE DACRON SUTURE (K903175)Advance Suture, Inc.1991-07-26
IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES (K905285)Internacional Farmaceutica, S.A. DE C.V.1991-02-11
FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE (K905440)United States Surgical, A Division of Tyco Healthc1991-01-31

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
NON-ABSORBABLE BLACK SILK SUTURE (N83074/S004)Look, Inc.1990-09-12
NON-ABSORBABLE BLACK SILK SUTURE (N83074/S002)Look, Inc.1986-06-09
POLYVIOLENE SUTURE (N80950/S003)Look, Inc.1986-06-09
POLYVIOLENE SUTURE (N80950/S002)Look, Inc.1986-02-28
POLYVIOLENE SUTURE (N80950/S001)Look, Inc.1985-03-22
NON-ABSORBABLE BLACK SILK SUTURE (N83074/S001)Look, Inc.1985-03-22