ENDOPROBES

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K922917 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the intended use of ENDOPROBES?

  ENDOPROBES are designed to provide visualization and access during minimally invasive surgical interventions in general and plastic surgery settings, as specified in the device description.

• How is ENDOPROBES supplied and by whom?

  ENDOPROBES are supplied by Endooptiks, Inc., located at 28 Marigold Ln., Marlboro, NJ 07746, United States, as indicated in the manufacturer and address fields of the device data.

• What regulatory pathway was used for ENDOPROBES clearance?

  ENDOPROBES received FDA 510(k) clearance through a traditional review process, as stated in the AUTHORIZATIONS and clearance_type fields, with decision code SESE indicating substantial equivalence.

• What is the product code and model number for ENDOPROBES?

  ENDOPROBES have the product code GEX and the specific model number K922917, as listed in the product_code and k_number fields of the device data.

• When was ENDOPROBES cleared by the FDA?

  ENDOPROBES received FDA clearance on September 28, 1992, as shown in the decision_date field, following submission on June 17, 1992, per the date_received field.