30977 See Sharp - Enhanced Intraoperative Laparoscope Cleaning & Defogging

FDA UDI

Class II (US FDA UDI)

by Xodus Medical, Inc.

Identity

Trade Name: 30977 See Sharp - Enhanced Intraoperative Laparoscope Cleaning & Defogging FDA UDI
Generic Name: Endoscope antifog solution FDA UDI
Device Name: 30977 See Sharp - Enhanced Intraoperative Laparoscope Cleaning & Defogging FDA UDI
Model / Reference: 30977 FDA UDI
Description: 30977 See Sharp - Enhanced Intraoperative Laparoscope Cleaning & Defogging FDA UDI

Identifiers

Catalog Number: 30977 FDA UDI
Primary DI / UDI-DI: 00787551037029 FDA UDI
510(k) Number: K182080 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Endoscope antifog solution FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Endoscope antifog solution

30977 See Sharp - Enhanced Intraoperative Laparoscope Cleaning & Defogging by Xodus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID

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Dr. Fog® Treated Sponge — Aspen Surgical Products, Inc. · Class II

Cleared under the same submission

K182080 also covers:

30978 See Sharp - Enhanced Intraoperative Laparoscope Cleaning & Defogging — XODUS MEDICAL, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Xodus Medical, Inc.

Sources (1)

FDA UDI 4c18db6f-7e31-407d-8d29-a488bbd2e3a7 36 fields · synced May 30, 2026