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510(k) K834541

H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48 by Imm Enterprises , Ltd. — Product Code GDX

K834541 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48". The FDA issued a decision of Substantially Equivalent on January 27, 1984. The device falls under product code GDX (Scalpel, One-Piece), a Class I device regulated under 21 CFR 878.4800. Imm Enterprises , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1984
Date Received
November 21, 1983
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 Imm Enterprises , Ltd.

  • K841387 — WESTON RECTAL SNARE (May 9, 1984)
  • K841386 — KOLLMANN URETHRAL DILATOR (May 9, 1984)
  • K840311 — CAT. 7-EAR, NOSE & THROAT DEVICES (May 9, 1984)
  • K840304 — CATEGORY 17-MICROBIOLOGY DEVICES (May 1, 1984)
  • K840305 — CATEGORY 1 CIRCULATORY SYSTEM DEVICE (April 23, 1984)
  • K840318 — CAT. 14-CLINICAL TOXIOLOGY DEVICES (April 23, 1984)
  • K840312 — CAT. 8 DENTAL DEVICES (April 5, 1984)
  • K834171 — OP-CON SURG. INSTRUMENT #3 (April 4, 1984)
  • K834191 — JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 (March 22, 1984)
  • K834192 — JAKOBI SURG. INSTRUMENTS #3 21/22/24 (March 22, 1984)

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

FDA data resources