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510(k) K822893

G.E.V. DISPOSABLE SCALPELS by Ascep, Inc. — Product Code GDX

K822893 is an FDA 510(k) premarket notification submitted by Ascep, Inc. for the device "G.E.V. DISPOSABLE SCALPELS". The FDA issued a decision of Substantially Equivalent on Oct 22, 1982. The device falls under product code GDX (Scalpel, One-Piece), a Class I device regulated under 21 CFR 878.4800. Ascep, Inc. has 8 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 22, 1982
Date Received
Sep 28, 1982
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
510(k) Exempt

Other clearances by Ascep, Inc.

  • K830219 — VARIOUS INSTRUMENTS & INSTRUMENT TRAYS (Apr 12, 1983)
  • K810004 — STERILE DISPOSABLE INSTRUMENT TRAYS (Jan 26, 1981)
  • K802726 — INSTRUMENTS NONSTERILE & STERILE (Nov 19, 1980)
  • K791886 — I.V. CARE KIT (Oct 26, 1979)
  • K791885 — I.V. START SET (Oct 22, 1979)
  • K791887 — CENTRAL VENOUS CATHETER DRESSING TRAY (Oct 17, 1979)
  • K791888 — CATHETER CARE KIT REORDER 7940&7941 (Oct 17, 1979)
  • K791889 — SUTURE REMOVAL TRAY, REORDER 7950&7951 (Oct 17, 1979)

Other clearances for product code GDX

  • K923689 — SURGISTAR BLADES (Sep 9, 1992)
  • K921167 — ULTRABLADE (Jul 30, 1992)
  • K914086 — ICAN CYLINDRICAL SPONGES (Oct 9, 1991)
  • K904505 — CCI CORNEAL SCARIFIER (Apr 23, 1991)
  • K905380 — 1-CUT ACL GRAFT KNIFE (Dec 13, 1990)
  • K895682 — VESSEL LOOPS (Oct 24, 1989)
  • K893033 — MINI-DIAMOND KNIFE (May 26, 1989)
  • K880028 — OMED DISPOSABLE SCALPEL (Jan 29, 1988)
  • K871894 — KCK INDUSTRIES' SURGICAL INSTRUMENTS (Jun 23, 1987)
  • K863950 — P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL (Oct 24, 1986)

FDA data resources

Source: FDA 510(k) database entry for K822893. Report a data issue: hello@regdatalab.com.