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Instrusafe In-2600-08-En

by Summit Medical, LLC

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Nov 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 10 Nov 2026. What this means

Regulatory status

as of registry sync 10 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00385640031011 UDI-DI Date5 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151166 Date18 Aug 2015DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 10 Nov 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Instrusafe
Generic name
Instrument tray, reusable
Model / reference
IN-2600-08-EN
Primary DI / UDI-DI
00385640031011
510(k) Number
FDA product code
KCT
GMDN term
Instrument tray, reusable
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution

Overview

AI-generated summary, 10 Nov 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Instrusafe IN-2600-08-EN is an instrument tray, reusable. It is a sterilization wrap container, tray, cassette, and other accessory. This device is identified by the brand name INSTRUSAFE and model number IN-2600-08-EN.

This device is Class II. It has FDA 510(k) clearances K051157, K133015, K140289, K141513, K142630, K142768, K150540, and K151166. The product code for this device is KCT under regulation 880.6850.

Related devices

Category: Instrument tray, reusable

Cleared under the same submission (K051157)

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Cleared under the same submission (K133015)

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Cleared under the same submission (K140289)

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Cleared under the same submission (K141513)

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Cleared under the same submission (K142630)

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Cleared under the same submission (K142768)

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Cleared under the same submission (K150540)

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Cleared under the same submission (K151166)

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Other devices from Summit Medical, LLC

See all devices from Summit Medical, LLC →

Questions

AI-generated answers, 10 Nov 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Instrusafe IN-2600-08-EN?

    It is recorded under the GMDN device type "Instrument tray, reusable", which GMDN defines as "A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures". FDA lists it under the product name "Sterilization Wrap Containers, Trays, Cassettes & Other Accessories". It is recorded as Class II.

  • What are the product code and regulation of the Instrusafe IN-2600-08-EN?

    FDA records the Instrusafe IN-2600-08-EN under product code KCT and regulation number 880.6850.

  • Who makes the Instrusafe IN-2600-08-EN?

    Summit Medical, LLC is the manufacturer on record for the Instrusafe IN-2600-08-EN.

Properties

  • Lot / batch number
  • Manufacturing date

Other properties (13)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No