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Titan SGS

by Standard Bariatrics

510(k) K210278

Titan SGS is a Class II device made by Standard Bariatrics, cleared under FDA 510(k) K210278 on 28 Apr 2021, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK210278 Date28 Apr 2021ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GDW
Device class
Class II
Regulation
21 CFR Part 878.4750
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K210278

8 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K210278
UDI-DISize and differences
TELEFLEX IPN928801
TELEFLEX INCORPORATED
SBC / IPN92880114026704921789
Single use: yes
On the market
TELEFLEX IPN928802
TELEFLEX INCORPORATED
SGS23R / IPN92880214026704921727
Single use: yes
On the market
TELEFLEX IPN928804
TELEFLEX INCORPORATED
SPU01 / IPN92880414026704921772
Single use: no
On the market
Titan SGS Bailout Chuck SBC
Standard Bariatrics
SBC / SBC00851677007102
Single use: yes
On the market
Titan SGS Standard Gastric Stapler SGS23R
Standard Bariatrics
SGS23R00851677007157
Single use: yes
On the market
Titan SGS Standard Gastric Stapler SGS23R
Standard Bariatrics
SGS23R00851677007089
Single use: yes
On the market
Titan SGS Standard Gastric Stapler SGS23Rb
Standard Bariatrics
SGS23Rb00851677007133
Single use: yes
On the market
TITAN Standard Power Unit SPU01
Standard Bariatrics
SPU0100851677007096
Single use: no
On the market

Similar devices

Other devices filed under FDA product code GDW (Staple, Implantable).

Other devices from Standard Bariatrics

See all devices from Standard Bariatrics →