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510(k) K822370

UNIVERSAL SPECULUM HOLDER by Treace Medical, Inc. — Product Code EPY

K822370 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "UNIVERSAL SPECULUM HOLDER". The FDA issued a decision of Substantially Equivalent on September 9, 1982. The device falls under product code EPY (Speculum, Ent), a Class I device regulated under 21 CFR 878.1800. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1982
Date Received
August 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Ent
Device Class
Class I
Regulation Number
878.1800
Review Panel
SU
Submission Type

Other clearances by Treace Medical, Inc.

  • K883727 — BUCKET PROSTHESIS PORP (January 13, 1989)
  • K882349 — MALLET, SURGICAL (June 23, 1988)
  • K874779 — BIPOLATOR 50 (January 29, 1988)
  • K873154 — TREACE MAGNUM OTO-TOOL SYSTEM (September 4, 1987)
  • K872000 — EYE GARD (July 21, 1987)
  • K870765 — CANNULATED INSTRUMENT CLEANERS (May 27, 1987)
  • K871706 — OPTHA PREP (May 18, 1987)
  • K870759 — CLEANING SOLUTION, CATALOG NO. 8203 (May 7, 1987)
  • K870766 — PROSTHESIS WIRE (April 15, 1987)
  • K870764 — SCHUKNECHT WIRE CUTTING SCISSORS (March 18, 1987)

Other clearances for product code EPY

  • K950086 — PEDIA PALS, INCORPORATED (February 7, 1995)
  • K925754 — ECONOM (October 8, 1993)
  • K853588 — FIBRELIGHT NASAL SPECULA (December 18, 1985)
  • K834189 — JAKOBI SURG. INSTRUMENTS #7 44/47 (March 6, 1984)
  • K822373 — EAR SURGERY SPECULUM (September 9, 1982)
  • K822164 — EAR SPECULI (August 11, 1982)
  • K791123 — EAR AND NOSE SPECULA (July 10, 1979)
  • K780723 — OTOSCOPE SPECULA (May 9, 1978)
  • K772370 — BARRAQUER OVAL SPECULUM-VARIOUS SIZES (January 17, 1978)
  • K772385 — THIN-BLADED NASAL SPECULUM (January 17, 1978)

FDA data resources