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510(k) K852057

ASCON SURGICAL INSTRUMENTS by Ascon Medical Instruments, Ltd. — Product Code HNR

K852057 is an FDA 510(k) premarket notification submitted by Ascon Medical Instruments, Ltd. for the device "ASCON SURGICAL INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on June 27, 1985. The device falls under product code HNR (Forceps, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Ascon Medical Instruments, Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1985
Date Received
May 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Ascon Medical Instruments, Ltd.

  • K852054 — CONTACT LENS LOUPE, INSPETION LOUPE (September 5, 1985)
  • K852055 — ASCON OPHTHALMIC SPONGE (September 4, 1985)
  • K852548 — ATL 225 MW TRAIL LENS SET (July 31, 1985)
  • K852056 — ACC CROSS CYLINDERS (June 5, 1985)
  • K852126 — ATF 101 TRAIL FRAME (June 5, 1985)

Other clearances for product code HNR

  • K022835 — STEPHENS DISPOSABLE FORCEPS (November 1, 2002)
  • K895434 — ALCON FOLDING FORCEPS (December 4, 1989)
  • K891487 — SOFT LENS FOLDING BLOCK (August 15, 1989)
  • K893199 — PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR (June 16, 1989)
  • K885230 — MCDONALD FOLDING FORCEPS (May 17, 1989)
  • K881049 — BRADBURY INTRAOCULAR RETINAL KIT CAT #200 (September 12, 1988)
  • K883197 — IOL IMPLANTATION FORCEPS (August 22, 1988)
  • K880274 — ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS (February 5, 1988)
  • K864266 — OPHTHALMIC KNIFE & FORCEPS (November 28, 1986)
  • K864183 — OPHTHALMIC SURGICAL INSTRUMENTS (November 28, 1986)

FDA data resources