510(k) K022777
- Device
- MANUAL TOUCHE SYSTEM
- Applicant
- ONUX MEDICAL, INC.
- 510(k) number
- K022777
- Product code
- GAQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-11-19
- Date received
- 2002-08-21
- Regulation
- 878.4495
- Classification name
- Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUTHANN DEPIETRO
- Address
- 5 Merrill Dr. Hampton NH US 03842 03842
FDA Registration Numbers#
- 3004060107
- 1018470
- 1000274611
- 1423537
- 3006425876
- 1219930
- 3014461810
- 2029275
- 3007791599
- 3029901632
- 3006981798
- 1221051
- 3015330532
- 3016904853
- 1043214
- 3015183635
- 2320762
- 3008812560
- 3014592276
- 2242056
- 3004215117
- 2210968
- 3013548553
- 3010452421
- 1054811
- 3017102971
- 3013403214
- 3012502601
- 3015718210
- 3038718579
- 1055236
- 3013298431
- 1424263
- 3009417901
- 1824313
- 2648650
- 1221601
- 3004111573
- 1721676
- 9680794
- 3014579161
- 3010692967
- 2648623
- 3006638824
- 3015212339
- 3017196117
- 2030624
- 2183301
- 9612501
- 9616088
- 3018094310
- 2032098
- 1833824
- 1064584
- 3005953126
- 3011137372
- 3012494290
- 3012421607
- 3010162973
- 3015399803
- 1054241
- 3008868758
- 3006562124
- 1061124
- 3032543753
- 3011276344
- 9611459
- 3014273254
- 3043226252
- 3018052045
- 3010041511
- 3011689956
- 3004365956
- 3004192065
Source Documents#
Other 510(k) Records For Product Code GAQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203855 | CoNextions TR Tendon Repair System | Conextions Medical | 2022-04-22 |
| K193209 | Wego-Stainless Steel | Foosin Medical Supplies Inc., Ltd. | 2020-02-19 |
| K172146 | MERISTEEL | M/s. Meril Endo Surgery Private Limited. | 2018-02-01 |
| K170767 | Surgical Stainless Steel Suture, Stainless Steel Suture | ETHICON, Inc. | 2017-11-01 |
| K141007 | DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE | Demetech Corp. | 2014-09-25 |
| K140127 | FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP | Pontis Orthopaedics, LLC | 2014-05-28 |
| K081060 | FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 | Core Essence Orthopaedics, LLC | 2008-12-24 |
| K082828 | SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE | Suturtek Incorporated | 2008-10-14 |
| K063603 | SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 | Suturtek Incorporated | 2007-02-07 |
| K042606 | MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE | Synthes (Usa) | 2005-05-27 |
| K041333 | SYNTHES (USA) TITANIUM WIRE | Synthes (Usa) | 2004-08-27 |
| K032468 | SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE | Suturtek Incorporated | 2003-09-23 |
| K023594 | TENO FIX | Ortheon Medical, LLC | 2003-05-15 |
| K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | Cp Medical | 2003-03-28 |
| K023411 | STEELEX STERNUM SET | Aesculap, Inc. | 2002-12-19 |
Legacy Summary#
summary
FDA Review#
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