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510(k) K912362

OES THORACOSCOPE SYSTEM by Olympus Corp. — Product Code EWY

K912362 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "OES THORACOSCOPE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 24, 1991. The device falls under product code EWY (Mediastinoscope, Surgical), a Class II device regulated under 21 CFR 874.4720. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1991
Date Received
May 29, 1991
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 Olympus Corp.

  • K915402 — EW-10 AND EW-20 (June 23, 1995)
  • K933200 — OLYMPUS PBD STENTS (April 5, 1995)
  • K942338 — OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES (November 30, 1994)
  • K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS (August 29, 1994)
  • K934835 — FLOVAL (June 21, 1994)
  • K931764 — HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES (June 8, 1994)
  • K915857 — FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE (March 11, 1994)
  • K931994 — RESECTOSCOPE SHEATH (February 17, 1994)
  • K934889 — OLYMPUS IMAGEMANAGER SYSTEM (January 28, 1994)
  • K934888 — OLYMPUS IMAGEMANAGERSYSTEM (January 25, 1994)

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)
  • K971166 — OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE (August 27, 1997)
  • K954910 — KARL STORZ OPTICAL MEDIASTINOSCOPE (November 3, 1995)
  • K930215 — FLEXIBLE TROCAR TUBES (March 16, 1993)
  • K913829 — OLYMPUS FLEXIBLE TIP THORACOSCOPE (November 22, 1991)

FDA data resources