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510(k) K863950

P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL by Precision Surgical Industries, Inc. — Product Code GDX

K863950 is an FDA 510(k) premarket notification submitted by Precision Surgical Industries, Inc. for the device "P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL". The FDA issued a decision of Substantially Equivalent on October 24, 1986. The device falls under product code GDX (Scalpel, One-Piece), a Class I device regulated under 21 CFR 878.4800. Precision Surgical Industries, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1986
Date Received
October 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scalpel, One-Piece
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Precision Surgical Industries, Inc.

  • K863951 — P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE (October 24, 1986)

Other clearances for product code GDX

  • K923689 — SURGISTAR BLADES (September 9, 1992)
  • K921167 — ULTRABLADE (July 30, 1992)
  • K914086 — ICAN CYLINDRICAL SPONGES (October 9, 1991)
  • K904505 — CCI CORNEAL SCARIFIER (April 23, 1991)
  • K905380 — 1-CUT ACL GRAFT KNIFE (December 13, 1990)
  • K895682 — VESSEL LOOPS (October 24, 1989)
  • K893033 — MINI-DIAMOND KNIFE (May 26, 1989)
  • K880028 — OMED DISPOSABLE SCALPEL (January 29, 1988)
  • K871894 — KCK INDUSTRIES' SURGICAL INSTRUMENTS (June 23, 1987)
  • K863213 — KEISEI SCALPEL (STERILE AND NON-STERILE) (September 2, 1986)

FDA data resources