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510(k) K971166

OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE by Richard Wolf Medical Instruments Corp. — Product Code EWY

K971166 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE". The FDA issued a decision of Substantially Equivalent on August 27, 1997. The device falls under product code EWY (Mediastinoscope, Surgical), a Class II device regulated under 21 CFR 874.4720. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1997
Date Received
March 31, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mediastinoscope, Surgical
Device Class
Class II
Regulation Number
874.4720
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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 EWY

  • K260003 — KARL STORZ Mediastinoscopes and Instruments (March 2, 2026)
  • K213194 — HD Mediastinoscope (June 23, 2022)
  • K202272 — HD Mediastinoscope (May 11, 2021)
  • K170757 — Aegis Transit System (July 14, 2017)
  • K160171 — Illuminated Mediastinal Access Port (February 26, 2016)
  • K141622 — ILLUMINATED MEDIASTINOSCOPE (January 9, 2015)
  • K954910 — KARL STORZ OPTICAL MEDIASTINOSCOPE (November 3, 1995)
  • K930215 — FLEXIBLE TROCAR TUBES (March 16, 1993)
  • K913829 — OLYMPUS FLEXIBLE TIP THORACOSCOPE (November 22, 1991)
  • K912362 — OES THORACOSCOPE SYSTEM (October 24, 1991)

FDA data resources