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510(k) K931793

SYMBIOSIS ENT SURGICAL INSTRUMENTS by Symbiosis Corp. — Product Code LRC

K931793 is an FDA 510(k) premarket notification submitted by Symbiosis Corp. for the device "SYMBIOSIS ENT SURGICAL INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on July 22, 1993. The device falls under product code LRC (Instrument, Ent Manual Surgical), a Class I device regulated under 21 CFR 874.4420. Symbiosis Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1993
Date Received
April 12, 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 Symbiosis Corp.

  • K955119 — SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES (January 18, 1996)
  • K953453 — SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES (January 17, 1996)
  • K953242 — SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES (October 6, 1995)
  • K952432 — SYMBIOSIS BIPOLAR FORCEPS (July 5, 1995)
  • K951387 — SYMBIOSIS BIPOLAR SCISSORS (April 10, 1995)
  • K950286 — SYMBIOSIS BIPOLAR SCISSORS (February 3, 1995)
  • K946238 — SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS (January 20, 1995)
  • K930773 — SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS (July 28, 1994)
  • K941426 — SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE (June 22, 1994)
  • K932266 — SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN (March 15, 1994)

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