Home / 510(k) Clearances / K984521

510(k) K984521

RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 by Richard Wolf Medical Instruments Corp. — Product Code EQL

K984521 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351". The FDA issued a decision of Substantially Equivalent on March 17, 1999. The device falls under product code EQL (Laryngostroboscope), a Class I device regulated under 21 CFR 874.4750. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1999
Date Received
December 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngostroboscope
Device Class
Class I
Regulation Number
874.4750
Review Panel
EN
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 EQL

  • K921184 — RLS 9100 RHINO-LARYNGEAL STROBOSCOPE (May 28, 1992)
  • K921285 — 9105 RIGID TELESCOPIC ENDOSCOPE (May 28, 1992)
  • K884933 — ENDOSTROBOSCOPE IV (February 15, 1989)
  • K842090 — RHINO-LARYNX STROBOSCOPE TYPE 4914 (July 18, 1984)
  • K822523 — LARYNGOSTROBOSCOPE (September 9, 1982)
  • K801866 — PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A (September 16, 1980)
  • K770466 — STOCKINGS, RVS TM (March 28, 1977)

FDA data resources