J. Jamner Surgical Instruments, Inc.
York, PA, US
J. Jamner Surgical Instruments, Inc. appears in FDA device records in York, PA. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for J. Jamner Surgical Instruments, Inc. between 1977 and 2008. The busiest year on record is 1994, with 4. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1993 | 3 |
| 1994 | 4 |
| 1995 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K082349 | JARIT HULKA UTERINE TENACULUM FORCEPS | HDC | Substantially Equivalent | |
| K944670 | JARIT RECOMMENDED SINUS INSTRUMENTS | EOB | Substantially Equivalent | |
| K944870 | JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680 | GCJ | Substantially Equivalent | |
| K941565 | JARIT RECOMMENDED SINUS INSTRUMENTS | EOB | Substantially Equivalent | |
| K932456 | JARIT SURGICAL INSTRUMENTS | KNF | Substantially Equivalent | |
| K933728 | JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-339 | GEI | Substantially Equivalent | |
| K931928 | JARIT SURGICAL INSTRUMENTS | GCJ | Substantially Equivalent | |
| K931959 | JARIT SURGICAL INSTRUMENTS | GEI | Substantially Equivalent | |
| K931878 | JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 680 | GCJ | Substantially Equivalent | |
| K771625 | LEININGEO AORTIC PUNCH #310-395 & 397 | DWS | Substantially Equivalent | |
| K771624 | COPE LUNG FORCEPS #305-218 | GEN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0596-2007 | JariTrak Table Clamp, 1 inch diameter, vertical post, Catalog Number 206-160. The JariTrak Table Clamp with vertical post (206-160) is part of the Table Mounted Hardware that is used with the JariTrak™ Retractor System. The JariTrak™ self-retaining retractor system consists of the Table Clamp with Vertical Post, Flexible or Horizontal Bar with Universal Joint, Oval or Segment Rings, Tilting Blade Clamps and various blades. The product is supplied non-sterile and may be packaged individually or as part of the JariTrak™ retractor set. | The JariTrak Table Clamp may not securely fasten to the bed rail of the OR table during set up of the retractor system. In the event that the clamp is not securely fastened to the bed rail, the system may move during surgery. The firm received several complaints from hospitals. | Terminated | ||
| Z-1506-06 | Ruggles Leyla Ball Joint Clamp, MODEL/CATALOG #: R2383 . The Leyla Ball Joint Clamp is part of the Table Mounting Hardware that is used with the Leyla Retractor System. The Leyla Table Mounting Hardware consists of the Ball Joint Clamp, the Rigid Holding Rod, the Coupling Head, and the Coupling Head Turn Table. The Ball Joint Clamp is available individually or as part of the Table Mount Set. The Table Mounting Hardware are attachments to operating room surgical tables. The product is supplied non-sterile and may be packaged individually or as part of the Table Mount Set. | The Ruggles Leyla Ball Joint Clamp may not properly tighten onto the Rigid Holding Rod. Although this condition can be observed during assembly, if the device were to be used during surgery, any attachments to the Rigid Holding Rod could move. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain