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510(k) K830522

STAINLESS STEEL SUTURE 316L by Sharpoint, Inc.

K830522 is an FDA 510(k) premarket notification submitted by Sharpoint, Inc. for the device "STAINLESS STEEL SUTURE 316L". The FDA issued a decision of Substantially Equivalent on Mar 31, 1983. Sharpoint, Inc. has 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 31, 1983
Date Received
Feb 17, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Sharpoint, Inc.

  • K863595 — COATED SUTURE NEEDLE (Oct 24, 1986)
  • K861947 — SURGICAL KNIFE (Jun 6, 1986)
  • K840764 — EAR KNIVES (May 21, 1984)
  • K840855 — CORNEAL SCLERAL LANCE (May 9, 1984)
  • K840659 — ANTERIOR CAPSULECTOMY CYSTITOME (Mar 16, 1984)
  • K840660 — POSTERIOR CAPSULOTOMY CYSTITOME (Mar 16, 1984)
  • K822112 — OPHTHALMIC KNIFE (Aug 10, 1982)
  • K821440 — V LANCE (Jun 14, 1982)

FDA data resources