510(k) K913829

OLYMPUS FLEXIBLE TIP THORACOSCOPE by Olympus Corp. — Product Code EWY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 22, 1991
Date Received: August 26, 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)
K912362 — OES THORACOSCOPE SYSTEM (October 24, 1991)