Home / 510(k) Clearances / K863951

510(k) K863951

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

K863951 is an FDA 510(k) premarket notification submitted by Precision Surgical Industries, Inc. for the device "P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE". The FDA issued a decision of Substantially Equivalent on October 24, 1986. The device falls under product code GDZ (Handle, Scalpel), 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
Handle, Scalpel
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Precision Surgical Industries, Inc.

  • K863950 — P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL (October 24, 1986)

Other clearances for product code GDZ

  • K091462 — SPECTRA MEDICAL SAFETY SCAPEL (December 15, 2009)
  • K890242 — SCALPEL HANDLE (January 27, 1989)
  • K884512 — BEAVER(R) HANDLE (November 17, 1988)
  • K863808 — THE S. CORDERO STYLUS (October 14, 1986)
  • K863212 — KEISEI HANDLES FOR SURGICAL BLADES (September 2, 1986)
  • K854858 — SCALPEL HANDLE (December 24, 1985)
  • K852735 — SCALPEL HANDLE #7 SS 410 OR 420 (July 15, 1985)
  • K852711 — SCALPEL HANDLE #3 SS 410 OR 420 (July 15, 1985)
  • K851750 — 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7 (June 20, 1985)
  • K852042 — BRIMFIELD CANNULATED BLADE HOLDER (June 11, 1985)

FDA data resources