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510(k) K834177

H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 by Imm Enterprises , Ltd. — Product Code HGE

K834177 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "H.R. JAKOBI SURG. INSTRUMENTS #4 30/31". The FDA issued a decision of Substantially Equivalent on December 27, 1983. The device falls under product code HGE (Amniotome), a Class I device regulated under 21 CFR 884.4530. Imm Enterprises , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1983
Date Received
November 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amniotome
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
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 HGE

  • K951148 — OBSTI-HOOK (June 9, 1995)
  • K926425 — AMNIPERF(TM) (March 7, 1994)
  • K910518 — GLOVE-N-GEL AMNIOTOMY KIT (May 9, 1991)
  • K871087 — S.C.M.T. PERFORATOR (March 23, 1987)
  • K850758 — AMNIGLOVE & AMNICOT (April 15, 1985)

FDA data resources