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510(k) K961931

PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP by R. K. Medical L. L. C. — Product Code GAL

K961931 is an FDA 510(k) premarket notification submitted by R. K. Medical L. L. C. for the device "PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP". The FDA issued a decision of Substantially Equivalent on July 29, 1996. The device falls under product code GAL (Suture, Absorbable, Natural), a Class II device regulated under 21 CFR 878.4830. R. K. Medical L. L. C. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1996
Date Received
May 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Natural
Device Class
Class II
Regulation Number
878.4830
Review Panel
SU
Submission Type

Other clearances by R. K. Medical L. L. C.

  • K961925 — POLYESTER NONABSORBABLE SURGICAL SUTURES USP (July 29, 1996)
  • K961389 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES (June 18, 1996)
  • K960328 — SILK NONABSORBABLE SURGICAL SUTURES USP (March 4, 1996)
  • K960327 — NYLON NOABSORBABLE SURGICAL SUTURES USP (March 4, 1996)

Other clearances for product code GAL

  • K142656 — Surgical Gut Suture (January 29, 2015)
  • K072930 — DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT (April 30, 2008)
  • K042287 — UNIPLAIN & UNICHROM (September 7, 2005)
  • K042897 — AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE (November 19, 2004)
  • K030227 — SUTURTEK FASTCLOSE SUTURING DEVICE (March 17, 2003)
  • K020597 — SERRALGUT (August 14, 2002)
  • K021043 — GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC (June 21, 2002)
  • K011105 — SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE (May 30, 2001)
  • K001299 — PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP (June 23, 2000)
  • K000542 — PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP (April 28, 2000)

FDA data resources