510(k) K832138
- Device
- Biomer * Pledget Suture Buttress
- Applicant
- ETHICON, INC.
- 510(k) number
- K832138
- Product code
- KGS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-05-23
- Date received
- 1983-07-01
- Regulation
- 878.4930
- Classification name
- Retention Device, Suture
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3014004349
- 3032391
- 1219602
- 9680143
- 3003761012
- 8040278
- 3010041511
- 2028924
- 3033520596
- 1020279
- 3008868758
- 3015173212
- 3012536737
- 3009905888
- 2030624
- 1724474
- 3004519921
- 3033589330
- 1064858
- 3011324393
- 3013722959
- 1064584
- 3016851379
- 1450662
- 1928237
- 3010667733
- 1836161
- 3013176080
- 3015309643
- 1319639
- 1424263
- 1219795
- 3005092287
- 8044098
- 3010273872
- 3010400367
- 2027062
- 3010331645
- 3008255748
- 3008744062
- 3005012805
- 3011642792
- 3006210673
- 3030564133
- 3011137372
- 1825034
- 1061927
- 3010882065
- 8022032
- 2029275
- 3035366890
- 3015718210
- 3009417901
- 1320468
- 1643264
- 1721504
- 9610612
- 3006950086
- 1721676
- 3000270450
- 3007366790
- 3012358417
- 1220246
- 3015869493
- 3038503932
- 9612278
- 1048735
- 3015231789
- 3012130008
- 3015207155
- 2132588
- 1226183
- 3005974802
- 3018094310
- 3008812560
- 3006981798
- 3020347218
- 8030607
- 1422634
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KGS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K030031 | SOFT TISSUE ANCHORING WASHERS | Accu-Speed, Incorporated | 2003-01-28 |
| K020480 | RBM | Smith & Nephew, Inc. | 2002-03-12 |
| K964935 | SUTURE LOCK | Smith & Nephew Endoscopy, Inc. | 1997-02-25 |
| K941740 | ACUFEX ROTATOR CUFF FIXATION BUTTON | Acufex Microsurgical, Inc. | 1995-06-30 |
| K930675 | MITEK CONE WASHER | Mitek Surgical Products, Inc. | 1993-11-09 |
| K904435 | VENTROFIL TENSION RELIEF SUTURE SET | Aesculap, Inc. | 1991-08-29 |
| K911225 | TRAY DOUGH | The Hygenic Corp. | 1991-04-17 |
| K904136 | SUTURE TENSION ADJUSTMENT REEL | Surgical Systems, Inc. | 1990-10-02 |
| K902001 | SURGICAL RETENTION BAR | Acufex Microsurgical, Inc. | 1990-05-09 |
| K896310 | ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE | Acufex Microsurgical, Inc. | 1989-11-20 |
| K893995 | DERMACARE TIE HOLDER | Dermacare | 1989-08-11 |
| K884565 | ACUFEX FIXATION BUTTON | Acufex Microsurgical, Inc. | 1989-02-27 |
| K883299 | SUTURE RETENTION DEVICE | Edwards Orthopaedics Div., Baxter Healthcare Corp. | 1988-08-23 |
| K872608 | HEWSON A.C.L. GUIDE SET | Concept, Inc. | 1987-09-16 |
| K863570 | LE VEEN WOUND SPLINT | Tek-Aid, Inc. | 1986-09-29 |