Question 1

What types of medical devices does Promepla manufacture?

Accepted Answer

Promepla specializes in devices primarily used in urology and gynecology. Their product line includes ureteral catheters like the RocaJJ and LumaFlex stents, designed for urinary drainage and obstruction relief. They also produce single-use stone retrieval baskets for biliary and urinary systems, endoscopic irrigation/aspiration systems, and specialized tubing sets for procedures such as hysteroscopy and transurethral resection. Additional products include guide wires, irrigation probes, and general-purpose fluid transfer sets, all tailored for surgical and diagnostic applications.

Question 2

Where is Promepla based, and what regulatory requirements do their devices follow?

Accepted Answer

Promepla is based in the United States. Their devices are regulated under FDA guidelines, with most falling into Class I or Class II categories, depending on their risk level and intended use. Since they operate domestically, their products must comply with U.S. medical device regulations, including mandatory registration and listing in relevant FDA databases.

Question 3

Which regulatory registries list Promepla’s devices?

Accepted Answer

Promepla’s devices are listed in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) database. These registries ensure traceability and compliance with U.S. medical device regulations, allowing healthcare providers and regulators to verify product details, classifications, and manufacturing information.

Question 4

How are Promepla’s devices classified under FDA regulations?

Accepted Answer

Promepla’s devices are classified under the FDA’s risk-based system, with most falling into Class I (low-risk, general controls) or Class II (moderate-risk, requiring special controls). For example, general-purpose catheters and connectors often qualify as Class I, while ureteral stents or stone retrieval baskets may require additional testing or performance standards, placing them in Class II. Classification depends on factors like intended use, patient contact duration, and potential risks.

Question 5

What is the primary purpose of Promepla’s ureteral catheters and stents?

Accepted Answer

Promepla’s ureteral catheters and stents, such as the RocaJJ and LumaFlex series, are designed to manage urinary obstructions by providing drainage pathways for urine flow. These polymeric stents are typically placed within the ureter to relieve blockages caused by conditions like kidney stones, strictures, or post-surgical adhesions. Their flexible and biocompatible design aims to minimize patient discomfort while maintaining long-term patency.

Device	Model / Reference	Registries	Class	Status
RocaJJ Soft Stent - Ø 4, 8 Fr - Length 26cm	ROJG9526ST	FDA UDI	Class II	Active
Urology - 1 WAY TURP / POST OPERATIVE Irrigation/Aspiration set	SOUR9212ST12	FDA UDI	Class II	Active
OlyCath Straight 0 Eye 8 French	ROTG8000ST245	FDA UDI	Class II	Active
ROCASTONE Extractor - 1.9Fr - Tipless Basket: 12mm - Assisted Closing	ROSZ1940ST	FDA UDI	Class II	Active
Tuohy Borst with Y Luer Lock	ROMYTB-ST245	FDA UDI	Class I	Active
ROCAWIRE Nitinol - 0, 035 Inch Length 180cm - 3cm Straight Flexible Tip	ROWP3503ST	FDA UDI	Class I	Active
LumaFlex Plus Double J stent, 2 open tips, Ch/Fr7/L.26cm, without wire	09-0183	FDA UDI	Class II	Active
BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cm	ROUS1235ST	FDA UDI	Class II	Active
ROCAWIRE PTFE - 0, 035 Inch Length 150cm - Removable Stylet	ROWG3502ST	FDA UDI	Class I	Active
Irrigation/Aspiration set for RTUP (Urology) 2 spikes-Pump Segment	RF0501T2S	FDA UDI	Class II	Active
BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cm	ROUS1245ST	FDA UDI	Class II	Active
Nitinol Stone Extractor, straight basket, 4 wires, 4FR	09-0020	FDA UDI	Class II	Active
XenX – Stone Management Device (7 cm tip Proximal Stone)	ROXE03807ST	FDA UDI	Class II	Active
Rio Tracer - Hydrophilic Dual Flexible .035x150cm	WG040135DF	FDA UDI	Class I	Active
ROCASTONE Extractor - Nitinol Flat Wire 2.5Fr - Basket: 16mm	ROSS2500ST	FDA UDI	Class II	Active
Urology - TURP Irrigation/Aspiration set (WITH PUMP SEGMENT)	SOUR9201ST12	FDA UDI	Class II	Active
KOBOT Filter Stone Extractor, 1.8 Fr Basket 14mm	09-0194	FDA UDI	Class II	Active
Laparoscopy - 1 Way Irrigation/Aspiration set + Handpiece (for Æ 5mm probe tip)	SOLA0500ST12	FDA UDI	Class II	Active
ROCASTONE Extractor - 2.2Fr - Tipless Basket: 16mm	ROSZ2200ST	FDA UDI	Class II	Active
Tuohy Borst 9 FR (11G) LLM	AC0101	FDA UDI	Class I	Active
Irrigation Tube	OSG00499E10ST35	EUDAMEDFDA UDI	Class I	Active
Y MMLL + Tuohy Borst 9 FR (11G)	ROMYTB-ST0	FDA UDI	Class I	Active
Irrigation/Aspiration set for RTUP/Post Operative irrigation (Urology)	RF0501TDE2SP	FDA UDI	Class II	Active
Irrigation tubing set for RTUP/Diagnostic	RF0501T2SD	FDA UDI	Class II	Active
Steel Guide Wire with PTFE Ø 0, 035", L. 150cm, straight with removable stylet	09-0012	FDA UDI	Class I	Active
OlyCath Straight 0 Eye 6 French	ROTG6000ST245	FDA UDI	Class II	Active
OlyCath Curved 0 Eye 7 French	ROTH7000ST245	FDA UDI	Class II	Active
Hydrophilic Nitinol Guidewire Ø 0.035”, L. 150cm, standard, with 3cm flexible J	09-0010	FDA UDI	Class I	Active
Urology - TURP / POST OPERATIVE Irrigation/Aspiration set (WITH PUMP SEGMENT)	SOUR9200ST12	FDA UDI	Class II	Active
Y MMLL + Tuohy Borst 9 FR (11G)	AC0101Y	FDA UDI	Class I	Active
Hydrophilic Nitinol Guidewire	09-0141	FDA UDI	Class I	Active
TRAXER FLOW use with gravity - Irrigation Line for Laser Ureteroscopy	ONGT2000ST12	FDA UDI	Class I	Active
Gynecology - 2 way Hysterescopy set	SOHY9200ST12	FDA UDI	Class II	Active
Endoflow II US - Single Chamber	MEN01US	FDA UDI	Class II	Active
RocaFlow Laparoscopy Tubing	SOLA9200ST245	FDA UDI	Class II	Active
TraxerFlow use with gravity - Irrigation Line for Laser Ureteroscopy	GL0101U	FDA UDI	Class I	Active
RocaJJ Soft Stent - Ø 7 Fr - Length 30cm	ROJS9730ST	FDA UDI	Class II	Active
JFil® Ureteral Suture Stent	ROJV5708ST	FDA UDI	Class II	Active
LumaFlex Double J stent, 2 open tips, Ch/Fr4, 8/L.22cm, without wire	09-0124	FDA UDI	Class II	Active
Urology Diagnostic TURP 2 Spike	RF2TUPD	FDA UDI	Class II	Active
Laparoscopy - 1 Way High Flow Irrigation/Aspiration set + Handpiece & probe (Æ	SOLA1033ST12	FDA UDI	Class II	Active
OlyCath Straight 2 Eye 7 French	ROTA7200ST245	FDA UDI	Class II	Active
RocaFlex Access Sheath & Dilation Catheter 12/14x45cm	AS121445	FDA UDI	Class II	Active
Nitinol Stone Extractor, TIPLESS basket 4 wires, 2.2 Fr	09-0028	FDA UDI	Class II	Active
LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.26cm, without wire	09-0130	FDA UDI	Class II	Active
RocaJJ Soft Stent - Ø 7 Fr - Length 24cm	ROJG9724ST	FDA UDI	Class II	Active
NaviBluTM : Nitinol Wire Hydrophilic Tip 0.035 inch 150 cm	09-0004	FDA UDI	Class I	Active
ROCASTONE Extractor - Nitinol Helical Wire 2.5Fr - Basket: 16mm	ROSH2500ST	FDA UDI	Class II	Active
Nitinol Stone Extractor, straight basket, 4 wires, 2.5 Fr	09-0019	FDA UDI	Class II	Active
Traxer Flow Dual Port- Irrigation set for Laser Ureteroscopy - 1 spike	09-0066	FDA UDI	Class II	Active

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