Home / 510(k) Clearances / K970345

510(k) K970345

ALIGNMENT INSTRUMENT by Richard Wolf Medical Instruments Corp. — Product Code HSZ

K970345 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "ALIGNMENT INSTRUMENT". The FDA issued a decision of Substantially Equivalent on April 29, 1997. The device falls under product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1997
Date Received
January 29, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

Other clearances by Richard Wolf Medical Instruments Corp.

  • K151282 — core nova Complete Operating Room Endoscopy (January 12, 2016)
  • K130423 — THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 (April 3, 2013)
  • K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 (September 20, 2012)
  • K120898 — KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR (August 3, 2012)
  • K090776 — MEGAPULSE LASER SYSTEM AND FIBERS (June 2, 2009)
  • K080617 — POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES (June 27, 2008)
  • K080977 — 3 CCD ENDOCAM 5550 (May 14, 2008)
  • K071292 — VIEW MD OFFICE SYSTEM, MODEL 41066.5540 (July 19, 2007)
  • K062720 — S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES (March 22, 2007)
  • K051276 — HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM (October 28, 2005)

Other clearances for product code HSZ

  • K991588 — EMS SWISS ORTHOCLAST (July 21, 1999)
  • K972860 — CURVTEK TSR SYSTEM (October 31, 1997)
  • K955084 — ASPACH 65,000 (MODIFICATION) (January 17, 1996)
  • K954080 — SODEM HIGH SPEED SYSTEM (October 16, 1995)
  • K944590 — ETHICON DRILL BIT AND DRILL GUIDE (May 11, 1995)
  • K934336 — SPINALPLANE (March 10, 1995)
  • K940276 — FILTER, DIFFUSER (November 16, 1994)
  • K942760 — PNEUMATIC WIRE TENSIONER (September 6, 1994)
  • K941681 — ARTHREX CIRCULAR HARVESTING SAW (August 25, 1994)
  • K935367 — TAVA WIRE-DRIVER (April 21, 1994)

FDA data resources