510(k) K951692

MIST ENDOSCOPIC PROBES by Mist, Inc. — Product Code GCJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 3, 1995
Date Received: April 12, 1995
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Laparoscope, General & Plastic Surgery
Device Class: Class II
Regulation Number: 876.1500
Review Panel: SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Mist, Inc.

K970937 — MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM) (September 26, 1997)
K971150 — MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE (September 23, 1997)
K952323 — MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES (June 23, 1995)
K952290 — MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED D (June 23, 1995)
K951648 — MIST ENDOSCOPIC NEEDLES (May 12, 1995)
K951481 — MIST ENDOSCOPIC CANNULAS (May 3, 1995)
K951480 — MIST TROCARS (May 3, 1995)

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