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510(k) K960328

SILK NONABSORBABLE SURGICAL SUTURES USP by R. K. Medical L. L. C. — Product Code GAP

K960328 is an FDA 510(k) premarket notification submitted by R. K. Medical L. L. C. for the device "SILK NONABSORBABLE SURGICAL SUTURES USP". The FDA issued a decision of SN on March 4, 1996. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030. R. K. Medical L. L. C. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
March 4, 1996
Date Received
January 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Silk
Device Class
Class II
Regulation Number
878.5030
Review Panel
SU
Submission Type

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

  • K961925 — POLYESTER NONABSORBABLE SURGICAL SUTURES USP (July 29, 1996)
  • K961931 — PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP (July 29, 1996)
  • K961389 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES (June 18, 1996)
  • K960327 — NYLON NOABSORBABLE SURGICAL SUTURES USP (March 4, 1996)

Other clearances for product code GAP

  • K241486 — Sofsilk™ Coated Braided Silk Suture (December 3, 2024)
  • K222944 — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Sutur (October 18, 2024)
  • K232355 — Non absorbable Surgical Silk Suture (January 16, 2024)
  • K221767 — Surgical Sutures with or without Needle (July 31, 2023)
  • K180701 — SafePath Suturing System (June 25, 2018)
  • K172149 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (October 20, 2017)
  • K162396 — SILK Surgical Suture (November 23, 2016)
  • K160623 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (May 31, 2016)
  • K080684 — WG-SURGICAL SUTURES WITH NEEDLE (June 9, 2008)
  • K071111 — NON-ABSORBABLE SILK SUTURE (July 17, 2007)

FDA data resources