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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 March 31, 1983. Sharpoint, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

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

Other clearances by Sharpoint, Inc.

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

FDA data resources