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510(k) K933770

FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE by Mahe-Medizintechnik — Product Code LRC

K933770 is an FDA 510(k) premarket notification submitted by Mahe-Medizintechnik for the device "FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE". The FDA issued a decision of Substantially Equivalent on March 23, 1994. The device falls under product code LRC (Instrument, Ent Manual Surgical), a Class I device regulated under 21 CFR 874.4420. Mahe-Medizintechnik has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1994
Date Received
July 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ent Manual Surgical
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Mahe-Medizintechnik

  • K942821 — MAHE INSTRUMENTS (November 2, 1994)
  • K942819 — TROCAR WITH SHIELD (August 23, 1994)
  • K933768 — COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES (June 27, 1994)
  • K933767 — FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY (May 26, 1994)
  • K935442 — MAHE INSTRUMENTS (March 14, 1994)
  • K933772 — PUNCH SURGICAL (February 1, 1994)
  • K925624 — MICROSURGICAL INSTRUMENTS (July 22, 1993)

Other clearances for product code LRC

  • K230258 — BB 8 Sinus Dilation Kit (May 25, 2023)
  • K212774 — VenSure LightGuide (February 4, 2022)
  • K201398 — SINUSPRIME Dilation System (October 15, 2020)
  • K201115 — Next Generation Balloon Dilation System (August 27, 2020)
  • K201472 — VenSure Balloon Device, VenSure Nav Balloon Device (August 26, 2020)
  • K181546 — Dillard Nasal Balloon Catheter (January 3, 2020)
  • K190525 — RELIEVA ULTIRRA Sinus Balloon Catheter (May 3, 2019)
  • K181838 — Sinusway Dilation System (December 20, 2018)
  • K172737 — MESIRE - Balloon Sinus Dilatation System (December 12, 2017)
  • K171687 — Relieva SpinPlus Nav Balloon Sinuplasty System (September 5, 2017)

FDA data resources