510(k) K961931
- Device
- PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP
- Applicant
- R.K. MEDICAL, L.L.C.
- 510(k) number
- K961931
- Product code
- GAL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-07-29
- Date received
- 1996-05-17
- Regulation
- 878.4830
- Classification name
- Suture, Absorbable, Natural
- 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
- BRENDA M KELLY
- Address
- One Lethbridge Plz. Suite 4 Mahwah NJ US 07430 07430
FDA Registration Numbers#
- 3013187142
- 1000274611
- 1423537
- 3008912871
- 3006425876
- 1219930
- 3008483449
- 3007791599
- 3029901632
- 3003418325
- 1058584
- 3014479313
- 3030733800
- 3007205024
- 3016904853
- 1043214
- 3015183635
- 2320762
- 1066741
- 3004215117
- 1450662
- 3027454646
- 2210968
- 3010452421
- 1054811
- 3017102971
- 3013403214
- 3012502601
- 3004944585
- 3038718579
- 1055236
- 3013298431
- 2648650
- 1221601
- 3004111573
- 1721676
- 3003267729
- 9680794
- 3010864832
- 3014579161
- 3010692967
- 2648623
- 3006638824
- 3015453963
- 3009380063
- 3017196117
- 2030624
- 2183301
- 9612501
- 9616088
- 3009968482
- 3018094310
- 2032098
- 3010131137
- 1064584
- 3005953126
- 3011137372
- 3012494290
- 3012421607
- 1054241
- 1061124
- 3032543753
- 3011276344
- 3014273254
- 3014461810
- 3004117249
- 3018052045
- 3010041511
- 3043226252
- 3011689956
- 3004365956
- 3004192065
Source Documents#
Other 510(k) Records For Product Code GAL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142656 | Surgical Gut Suture | Covidien | 2015-01-29 |
| K072930 | DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT | Demetech Corp. | 2008-04-30 |
| K042287 | UNIPLAIN & UNICHROM | United Medical Industries Co. , Ltd. | 2005-09-07 |
| K042897 | AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE | Ethicon Endo-Surgery, Inc. | 2004-11-19 |
| K030227 | SUTURTEK FASTCLOSE SUTURING DEVICE | Suturtek Incorporated | 2003-03-17 |
| K020597 | SERRALGUT | Serral, S.A. DE C.V. | 2002-08-14 |
| K021043 | GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC | Gramsmed, LLC | 2002-06-21 |
| K011105 | SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE | Qrc Consulting | 2001-05-30 |
| K001299 | PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP | Cp Medical | 2000-06-23 |
| K000542 | PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-28 |
| K993695 | LIGA-LOOP SUTURE APPLICATOR | Hysterx, Inc. | 2000-04-13 |
| K994002 | PLAIN/CHROMIC CATGUT | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 |
| K982646 | AILEE SUTURES AND AILEE NEEDLES | Myco Medical Supplies, Inc. | 1999-06-02 |
| K991223 | ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC | Aesculap, Inc. | 1999-04-30 |
| K943217 | PLAIN CATGUT | Sutures , Ltd. | 1994-12-05 |
Legacy Summary#
summary
FDA Review#
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