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Gdls-200

by Gc America Inc.

510(k) K082434

Gdls-200 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K082434 on 14 Nov 2008, 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 NumberK082434 Date14 Nov 2008ClearedStatusActive

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  • Withdrawn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
EBF
FDA applicant
GC America, Inc.
Device class
Class II
Regulation
21 CFR Part 872.3690
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

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

Cited by

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

Devices cleared under K082434

108 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 K082434
UDI-DISize and differences
KALORE™ 003569
Gc America Inc.
003569 / 003569D0470035691
Single use: yes
On the market
KALORE™ 003569
Gc America Inc.
003569 / 00356914548161322805
Single use: yes
On the market
KALORE™ 003572
Gc America Inc.
003572 / 003572D0470035721
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003573
Gc America Inc.
003573 / 00357314548161293075
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003574
Gc America Inc.
003574 / 003574D0470035741
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003575
Gc America Inc.
003575 / 003575D0470035751
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003576
Gc America Inc.
003576 / 003576D0470035761
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003578
Gc America Inc.
003578 / 00357814548161293129
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003578
Gc America Inc.
003578 / 003578D0470035781
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003579
Gc America Inc.
003579 / 003579D0470035791
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003582
Gc America Inc.
003582 / 00358214548161293167
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003582
Gc America Inc.
003582 / 003582D0470035821
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003584
Gc America Inc.
003584 / 003584D0470035841
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003587
Gc America Inc.
003587 / 003587D0470035871
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003589
Gc America Inc.
003589 / 00358914548161293235
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003590
Gc America Inc.
003590 / 003590D0470035901
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003591
Gc America Inc.
003591 / 00359114548161293259
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003593
Gc America Inc.
003593 / 003593D0470035931
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003594
Gc America Inc.
003594 / 003594D0470035941
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003594
Gc America Inc.
003594 / 00359414548161293280
Total Volume 2 mL
Single use: no
On the market
KALORE™ 003598
Gc America Inc.
003598 / 003598D0470035981
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003599
Gc America Inc.
003599 / 003599D0470035991
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003600
Gc America Inc.
003600 / 00360014548161293341
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003601
Gc America Inc.
003601 / 00360114548161291163
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003602
Gc America Inc.
003602 / 00360214548161291170
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003603
Gc America Inc.
003603 / 00360314548161291187
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003604
Gc America Inc.
003604 / 00360414548161291194
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003604
Gc America Inc.
003604 / 003604D0470036041
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003605
Gc America Inc.
003605 / 00360514548161291200
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003606
Gc America Inc.
003606 / 003606D0470036061
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003607
Gc America Inc.
003607 / 00360714548161291224
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003608
Gc America Inc.
003608 / 003608D0470036081
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003608
Gc America Inc.
003608 / 00360814548161291231
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003610
Gc America Inc.
003610 / 003610D0470036101
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003611
Gc America Inc.
003611 / 00361114548161291262
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003612
Gc America Inc.
003612 / 00361214548161291279
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003613
Gc America Inc.
003613 / 00361314548161291286
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003613
Gc America Inc.
003613 / 003613D0470036131
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003614
Gc America Inc.
003614 / 00361414548161291293
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003614
Gc America Inc.
003614 / 003614D0470036141
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003615
Gc America Inc.
003615 / 00361514548161291309
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003616
Gc America Inc.
003616 / 00361614548161291316
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003617
Gc America Inc.
003617 / 00361714548161291323
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003617
Gc America Inc.
003617 / 003617D0470036171
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003618
Gc America Inc.
003618 / 00361814548161291330
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003619
Gc America Inc.
003619 / 003619D0470036191
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003620
Gc America Inc.
003620 / 003620D0470036201
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003621
Gc America Inc.
003621 / 00362114548161291361
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003622
Gc America Inc.
003622 / 00362214548161291378
Total Volume 0.16 mL
Single use: yes
On the market
KALORE™ 003624
Gc America Inc.
003624 / 003624D0470036241
Single use: no
On the market

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