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510(k) K963377

EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC by North Eos Industries, Inc. — Product Code HIB

K963377 is an FDA 510(k) premarket notification submitted by North Eos Industries, Inc. for the device "EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC". The FDA issued a decision of Substantially Equivalent on October 4, 1996. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. North Eos Industries, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1996
Date Received
August 27, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Nonmetal
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by North Eos Industries, Inc.

  • K963685 — EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER (October 11, 1996)
  • K954614 — EOS BRAND DISPOSABLE PROCTOSCOPE (April 10, 1996)

Other clearances for product code HIB

  • K252208 — JFord Speculum Sleeve™ (March 6, 2026)
  • K133857 — BRELLA-SPEC(TM) VAGINAL SPECULUM (April 28, 2014)
  • K132668 — IOB DISPOSABLE SPECULUM (January 17, 2014)
  • K130046 — CLEARSPEC SINGLE USE VAGINAL SPECULUM (August 6, 2013)
  • K120743 — SPECULUM, VAGINAL, NONMETAL (March 23, 2012)
  • K110766 — KOLPLUX SYSTEM (September 15, 2011)
  • K092870 — NON-STERILE DISPOSABLE VAGINAL SPECULUM (February 16, 2010)
  • K091937 — OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM (September 9, 2009)
  • K072942 — MEDLINE DISPOSABLE VAGINAL SPECULUM (February 8, 2008)
  • K072762 — DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM (January 22, 2008)

FDA data resources