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510(k) K911932

J105 JAMES SURGICAL SYSTEM I/A PACK by O.R. Specialties, Inc. — Product Code GZX

K911932 is an FDA 510(k) premarket notification submitted by O.R. Specialties, Inc. for the device "J105 JAMES SURGICAL SYSTEM I/A PACK". The FDA issued a decision of Substantially Equivalent on August 26, 1991. The device falls under product code GZX (Instrument, Microsurgical), a Class I device regulated under 21 CFR 882.4525. O.R. Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1991
Date Received
April 30, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Microsurgical
Device Class
Class I
Regulation Number
882.4525
Review Panel
NE
Submission Type

Other clearances by O.R. Specialties, Inc.

  • K942607 — LAPAROSCOPIC SCISSORS (DISPOSABLE) (July 6, 1994)
  • K923630 — PHACO NEEDLES 1000-R & 1000-O NEEDLES (April 6, 1994)
  • K925671 — DISPOSABLE SCLERAL PLUGS (August 2, 1993)
  • K923887 — JACK'S VENT TUBES (February 19, 1993)
  • K923774 — DISPOSABLE ENDOILLUMINATOR (October 19, 1992)
  • K922355 — POLLY'S VITREOUS SCISSORS J-225-S (August 18, 1992)
  • K922180 — LEWICKY O.R.S. TUBING (July 2, 1992)
  • K914038 — POLLY'S CUTTER J-225 (December 9, 1991)
  • K890195 — JAMES SURGICAL SYSTEM J1000 (August 3, 1989)
  • K890825 — JUMPER PACK #203 (May 26, 1989)

Other clearances for product code GZX

  • K932169 — MICROSURGICAL INSTRUMENTS (July 20, 1993)
  • K926048 — CLARUS ENDOSCOPIC BALL PROBE (April 7, 1993)
  • K890216 — MICROSURGICAL KERATOME (February 16, 1989)
  • K873933 — RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM (December 17, 1987)
  • K873934 — RANGE OF CROCODILE ACTION INSTRUMENTS (December 17, 1987)
  • K862971 — MICRA MICROSURGICAL INSTRUMENTS (August 25, 1986)
  • K853179 — VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND (November 7, 1985)
  • K853161 — THE VICKERS STANDARD MICROSURGERY SET (November 7, 1985)
  • K853180 — VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED (October 28, 1985)
  • K853181 — VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED (October 28, 1985)

FDA data resources