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510(k) K864071

FAULKNER FORCEPS by Staar Surgical Co. — Product Code HNR

K864071 is an FDA 510(k) premarket notification submitted by Staar Surgical Co. for the device "FAULKNER FORCEPS". The FDA issued a decision of Substantially Equivalent on November 13, 1986. The device falls under product code HNR (Forceps, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Staar Surgical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1986
Date Received
October 20, 1986
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 Staar Surgical Co.

  • K172375 — MicroSTAAR Injector System Cartridges (September 6, 2017)
  • K152357 — MicroSTAAR Injector System Cartridges (October 30, 2015)
  • K090161 — EPIPHANY INJECTION SYSTEM (June 9, 2009)
  • K073591 — MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM (March 13, 2008)
  • K073586 — MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM (March 13, 2008)
  • K032412 — RE-USEABLE MICROSTAAR INJECTOR, MSI-S (June 10, 2004)
  • K020734 — SURGE-FREE ASPIRATION ADAPTER (May 16, 2002)
  • K983129 — DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (December 4, 1998)
  • K980696 — FOAM TIP INJECTOR (September 11, 1998)
  • K954600 — MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) (December 21, 1995)

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