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Ot-1700

by Summit Medical, LLC

Ot-1700 is a tympanostomy tube (FDA Class II; FDA product code ETD, Tube, Tympanostomy) made by Summit Medical, LLC, cleared under FDA 510(k) K991670 on 26 Aug 1999 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00385640014601), active as of 23 Oct 2026.

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 23 Oct 2026

Documents

510(k) K991670

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00385640014601 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK991670 Date26 Aug 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K991670 decided 26 Aug 1999 Active
  • FDA GUDID UDI-DI 00385640014601 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K991670
  2. Listed FDA GUDID 00385640014601

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Tympanostomy tube
Model / reference
OT-1700
Primary DI / UDI-DI
00385640014601
510(k) Number
FDA product code
ETD
GMDN term
Tympanostomy tube
Device class
Class II
Regulation number
874.3880
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tympanostomy tube

Similar devices in this category

Other devices filed under Tympanostomy tube.

Other devices from Summit Medical, LLC

See all devices from Summit Medical, LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)