Home / 510(k) Clearances / K022836

510(k) K022836

STEPHENS DISPOSABLE SPECULUM by Stephens Instruments — Product Code HNC

K022836 is an FDA 510(k) premarket notification submitted by Stephens Instruments for the device "STEPHENS DISPOSABLE SPECULUM". The FDA issued a decision of Substantially Equivalent on November 1, 2002. The device falls under product code HNC (Specula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Stephens Instruments has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2002
Date Received
August 27, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Specula, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Stephens Instruments

  • K022842 — STEPHENS DISPOSABLE HOOKS (November 1, 2002)
  • K022840 — STEPHENS DISPOSABLE SCISSORS (November 1, 2002)
  • K022835 — STEPHENS DISPOSABLE FORCEPS (November 1, 2002)
  • K022843 — GAYHEART CORNEAL EXCISION DEVICE (November 1, 2002)

Other clearances for product code HNC

  • K981235 — OCULOSTAT (July 15, 1998)
  • K964289 — EYE FIXATION SPECULUM (December 17, 1996)
  • K863989 — THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) (October 31, 1986)
  • K863664 — OPHTHALMIC SURGICAL SPECULUM (September 25, 1986)
  • K843196 — VISITEC EYE SPECULUM (October 5, 1984)
  • K830430 — EYELID SPECULUM (June 10, 1983)
  • K801969 — ASNIS GUIDED SCREW SYSTEMS (August 27, 1980)
  • K760847 — FELDSTEIN BLEPHAROPLASTY CLIP SHARP P (November 2, 1976)
  • K760849 — FELDSTEIN BLEPHAROSTOMY CLIP SQUARE (November 2, 1976)
  • K760848 — FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU (November 2, 1976)

FDA data resources